Prosthetic heart valves

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser. No. 19/085,135 filed on Mar. 20, 2025, which claims the benefit of U.S. Provisional Application Ser. No. 63/757,042 filed on Feb. 11, 2025. The disclosure of the prior applications are considered part of (and are incorporated by reference in) the disclosure of this application.

FIELD OF INVENTION

This disclosure generally relates to prosthetic heart valve systems. For example, this disclosure relates to prosthetic heart valves and catheter-based deployment systems that are used to replace a sub-optimally functioning native heart valve, including but not limited to a tricuspid valve.

BACKGROUND

A human heart includes four types of heart valves that are arranged to ensure blood flow in specific directions: mitral, tricuspid, aortic and pulmonary valves. The aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart, and prevent blood from flowing back into left ventricle and right ventricle respectively when closed. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, and prevent blood from flowing back into left atrium and right atrium respectively when closed. Conditions of stenosis (when valve does not open fully) as well as regurgitation/insufficiency (when valve does not close properly resulting in leaks) are recognized as significant contributors to mortality and morbidity.

Some valve replacement systems include a valve prosthesis that is compressed into a delivery catheter, also referred to as transcatheter valves, so as to avoid open-heart surgery. Many transcatheter valve prostheses have a tubular frame that may or may not be axisymmetric, and include an occluder that has two or more leaflets. While these transcatheter valve prostheses can be compressed into a catheter, they may still require a relatively large delivery system (for example, a required catheter size of up to 45 French). This is especially true in case of mitral valve replacement systems and tricuspid valve replacement systems, which often require valve prostheses with a larger delivery profile.

SUMMARY

Some embodiments described herein include a prosthetic valve system that includes a prosthetic valve system and a valve deployment system. The prosthetic heart valve includes a main body including an inflow end portion and an outflow end portion and one or more anterior flaps extending from the outflow end portion. The main body defines a central axis extending between the inflow and outflow end portions. The one or more anterior flaps extend in a first direction that is transverse to the central axis. The valve deployment system includes: an elongate control catheter defining one or more lumens and comprising a naturally curved end portion; a third control wire slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps; and a suture or wire member releasably coupled to the third control wire. The valve deployment system is configured so that adding tension to the suture or wire member adjusts a curvature of the elongate control catheter in a direction of the one or more anterior flaps.

Such a prosthetic valve system may optionally include one or more of the following features. The system may include a retrieval catheter with an expandable conical end portion. The suture or wire member may be attached to the retrieval catheter. The inflow end portion of the main body may have a smaller outer size than an outer size of the outflow end portion of the main body. The valve deployment system may also include a first control wire comprising a first wire loop that extends out of the one or more lumens and that is releasably coupled to the inflow end portion of the main body. The valve deployment system may also include a second control wire comprising a second wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion. The third control wire may include a single wire segment that extends out of the one or more lumens, releasably couples with the one or more anterior flaps and the suture or wire member and terminates in releasable engagement with a distal tip portion of the control catheter. The valve deployment system may also include a deflectable catheter defining a lumen. A portion of the control catheter may be slidably disposable within the lumen of the deflectable catheter. The valve deployment system may also include a fifth control wire slidably coupled with the deflectable catheter. The prosthetic heart valve may also include a posterior arm extending from the inflow end portion of the main body. In some embodiments, the fifth control wire comprises a single wire segment that releasably couples with the posterior arm and terminates in releasable engagement with a distal tip portion of the deflectable catheter. A distal end portion of the deflectable catheter may be selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system. The one or more anterior flaps may include a septal anterior flap and a lateral anterior flap. An edge portion of the septal anterior flap may include a septal anterior strut framework, and an edge portion of the lateral anterior flap may include a lateral anterior strut framework. The septal anterior strut framework may include S-shaped struts. The lateral anterior strut framework may include L-shaped struts. The outflow end portion of the main body may extend to a farthest end of the prosthetic heart valve.

In another aspect, this disclosure is directed to a prosthetic heart valve that includes a main body including an inflow end portion and an outflow end portion, the main body defining a central axis extending between the inflow and outflow end portions; a plurality of suture knots protruding from an external surface of the main body; and one or more anterior flaps extending from the outflow end portion in a first direction that is transverse to the central axis.

Such a prosthetic heart valve may optionally include one or more of the following features. In some embodiments, the plurality of suture knots are only attached to the external surface of the outflow end portion of the main body. In some embodiments, the plurality of suture knots are only attached to lateral and septal external surfaces of the outflow end portion. The one or more anterior flaps may include a septal anterior flap and a lateral anterior flap. An edge portion of the septal anterior flap may include a septal anterior strut framework, and an edge portion of the lateral anterior flap may include a lateral anterior strut framework. The septal anterior strut framework may include S-shaped struts. The lateral anterior strut framework may include L-shaped struts.

Any of the prosthetic heart valves described herein may optionally include one or more of the following additional features. In some embodiments, portions of the first anterior flap and the second anterior flap overlap each other. The prosthetic tricuspid valve may also include a posterior flap extending laterally from the end of the main body in an opposite direction as the first and second anterior flaps. In some embodiments, the first and second anterior flaps extend farther laterally than the posterior flap. In particular embodiments, the first and second anterior flaps in combination are wider (in the septal to lateral direction) than the posterior flap. A framework of the prosthetic tricuspid valve (that comprises the main body, the first and second anterior flaps, and the posterior flap) may be made of a single, unitary material that was cut and expanded. In some embodiments, a distal tip portion of the posterior flap extends along an axis that is at a non-zero angle relative to a portion of the posterior flap that extends directly from the main body. In some examples, having the portions of the first anterior flap and the second anterior flap that overlap each other increases a bending resistance of the first anterior flap and the second anterior flap in combination as compared to the first anterior flap and the second anterior flap individually. Having the portions of the first anterior flap and the second anterior flap as separate members or regions can configure the prosthetic tricuspid valve to have a pacemaker lead pass through the prosthetic tricuspid valve between the first and second anterior flaps. The prosthetic tricuspid valve may also include one or more additional anterior flaps extending laterally from the end of the main body in the same direction as the first and second anterior flaps. The prosthetic tricuspid valve may also include two or more posterior flaps extending laterally from the end of the main body in an opposite direction as the first and second anterior flaps. Having the portions of the first posterior flap and the second posterior flap as separate members or regions can configure the prosthetic tricuspid valve to have a pacemaker lead pass through the prosthetic tricuspid valve between the first and second posterior flaps. In some embodiments, a transverse cross-section of the main body has an oval shaped outer profile that defines a major diameter and a minor diameter. The minor diameter is shorter than the major diameter. The occluder may have a circular cross-sectional shape, and the anterior and posterior flaps may extend transversely to the major diameter. The prosthetic heart valve may also include a leaflet engagement member extending from the main body, a portion of the leaflet engagement member extending toward the inflow end portion and terminating at a free end. The leaflet engagement member may extend in the second direction. The posterior flap may extend farther away from the main body than the leaflet engagement member.

BRIEF DESCRIPTION OF FIGURES

<figref idref="DRAWINGS">FIG. <b>1</b></figref> shows a sectional view of a human heart including four heart valves (mitral valve, tricuspid valve, aortic valve, and pulmonary valve) that allow blood flow through specific pathways. The mitral and tricuspid valve are arranged to normally prevent backflow of blood into left atrium and right atrium respectively when the left and right ventricle contract respectively.

<figref idref="DRAWINGS">FIG. <b>2</b></figref> shows a top view of the tricuspid valve of <figref idref="DRAWINGS">FIG. <b>1</b></figref> and including three native leaflets: anterior, posterior and septal.

<figref idref="DRAWINGS">FIG. <b>3</b></figref> shows another sectional view of a human heart including the four chambers (right atrium, right ventricle, left atrium, and left ventricle) and major conduits that deliver blood to the heart and transport blood away from the heart.

<figref idref="DRAWINGS">FIG. <b>4</b></figref> shows a side view of an example prosthetic heart valve in accordance with some embodiments described herein.

<figref idref="DRAWINGS">FIG. <b>5</b></figref> shows a side view of the prosthetic heart valve of <figref idref="DRAWINGS">FIG. <b>4</b></figref> engaged within a native tricuspid valve.

<figref idref="DRAWINGS">FIG. <b>6</b></figref> shows a top view of the prosthetic heart valve of <figref idref="DRAWINGS">FIG. <b>4</b></figref>.

<figref idref="DRAWINGS">FIG. <b>7</b></figref> shows a top view of a frame of another example prosthetic heart valve in accordance with some embodiments described herein.

<figref idref="DRAWINGS">FIG. <b>8</b></figref> illustrates an example transcatheter prosthetic heart valve deployment system in accordance with some embodiments.

<figref idref="DRAWINGS">FIG. <b>9</b></figref> is an enlarged view of the distal end portion of the transcatheter prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIG. <b>10</b></figref> is a first cross-sectional view of a control catheter of the transcatheter prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIG. <b>11</b></figref> is a second cross-sectional view of the control catheter of the transcatheter prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIG. <b>12</b></figref> is a third cross-sectional view of the control catheter of the transcatheter prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIG. <b>13</b></figref> shows a top or atrial view of an example prosthetic heart valve including indications of example locations to which control wires are releasably coupled for deploying the prosthetic valve using the transcatheter prosthetic heart valve deployment systems described herein.

<figref idref="DRAWINGS">FIG. <b>14</b></figref> shows a bottom or ventricular view of the example prosthetic heart valve of <figref idref="DRAWINGS">FIG. <b>13</b></figref>, including indications of example locations to which control wires are releasably coupled for deploying the prosthetic valve using the transcatheter prosthetic heart valve deployment systems described herein.

<figref idref="DRAWINGS">FIG. <b>15</b></figref> shows an example prosthetic heart valve that is releasably coupled by control wires to a distal end portion of an example transcatheter prosthetic heart valve deployment system described herein.

<figref idref="DRAWINGS">FIG. <b>16</b></figref> schematically illustrates a side view of the prosthetic tricuspid valves described herein.

<figref idref="DRAWINGS">FIG. <b>17</b></figref> schematically shows the prosthetic tricuspid valve of <figref idref="DRAWINGS">FIG. <b>16</b></figref> coupled with the prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>10</b></figref>.

<figref idref="DRAWINGS">FIG. <b>18</b></figref> shows a perspective view of an example control handle of a transcatheter prosthetic heart valve deployment system in accordance with some embodiments.

<figref idref="DRAWINGS">FIG. <b>19</b></figref> schematically shows the control handle of <figref idref="DRAWINGS">FIG. <b>18</b></figref> in a first orientation.

<figref idref="DRAWINGS">FIG. <b>20</b></figref> schematically shows the control handle of <figref idref="DRAWINGS">FIG. <b>18</b></figref> in a second orientation.

<figref idref="DRAWINGS">FIGS. <b>21</b>-<b>23</b></figref> show various orientations of an example control wire that is coupled to a distal end portion of a control catheter of the prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIGS. <b>24</b>-<b>26</b></figref> show various orientations of another example control wire that is coupled to a distal end portion of a control catheter of the prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIGS. <b>27</b> through <b>36</b></figref> show an example transjugular method of deploying the prosthetic tricuspid valves described herein using the prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIG. <b>37</b></figref> shows the distal end portion of an example retrieval catheter that is included in some embodiments of the prosthetic heart valve deployment system of <figref idref="DRAWINGS">FIG. <b>8</b></figref>.

<figref idref="DRAWINGS">FIGS. <b>38</b>-<b>44</b></figref> sequentially illustrate the retrieval catheter of <figref idref="DRAWINGS">FIG. <b>37</b></figref> being used to recapture a prosthetic heart valve in accordance with some implementations.

DETAILED DESCRIPTION

Some embodiments described herein include a prosthetic heart valve that may be delivered to a targeted native heart valve site via a deployment system that includes one or more delivery catheters. In some embodiments, the prosthetic heart valve may be releasably coupled to the one or more delivery catheters using one or more control wires. The control wires can be individually manipulated by a clinician-user at a handle of the deployment system to expand and/or deploy particular portions of the prosthetic heart valve in a controlled manner.

In particular implementations, the deployment systems described herein can include a retrieval catheter that can be used to recapture the prosthetic heart valve back into a delivery sheath after being expressed from the delivery sheath.

Some delivery catheter systems described herein can include a curved control catheter and/or a selectively deflectable/steerable catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

In some embodiments, the prosthetic heart valves described herein include one or more structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance during diastole and systole. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart.

Referring to <figref idref="DRAWINGS">FIG. <b>1</b></figref>, certain aspects of the concepts described herein regarding the heart valve replacement systems can be implemented in prosthetic valve designs that are intended for use at any of the four heart valves that allow blood flow through a specific pathway: mitral valve, tricuspid valve, aortic valve and the pulmonary valve. <figref idref="DRAWINGS">FIG. <b>2</b></figref> depicts, for example, a targeted site at a tricuspid valve <b>10</b> of the heart. The tricuspid valve <b>10</b> includes an anterior leaflet <b>11</b><i>a</i>, a posterior leaflet <b>11</b><i>p</i>, and a septal leaflet <b>11</b><i>s</i>, and an annulus <b>12</b>. In some circumstances, the tricuspid valve <b>10</b> may undergo stenosis or anatomical changes that cause tricuspid regurgitation, such as instances in which the distance between the anterio-septal commissure and the anterio-posterior commissure of the native tricuspid valve increases with the progression of a diseased state due to dilation of the annulus <b>12</b> of the tricuspid valve <b>10</b>.

<figref idref="DRAWINGS">FIG. <b>3</b></figref> illustrates a longitudinal sectional view of a human heart <b>1</b> that shows the four chambers (right atrium, right ventricle, left atrium, and left ventricle) and the major conduits that deliver blood to the heart <b>1</b> and transport blood away from the heart <b>1</b>. The tricuspid valve <b>10</b> is located between the right atrium and the right ventricle. Blood enters the right atrium from the superior vena cava and the inferior vena cava. Blood flows from the right atrium to the right ventricle through the tricuspid valve <b>10</b>. The blood exits the right ventricle and enters the main pulmonary artery (“MPA”) via the RVOT that is adjacent to the tricuspid valve <b>10</b>.

<figref idref="DRAWINGS">FIGS. <b>4</b>-<b>6</b></figref> illustrate an example prosthetic tricuspid valve <b>100</b> (or simply “valve <b>100</b>”) in accordance with some example embodiments of this disclosure. The valve <b>100</b> includes a frame <b>102</b> and a covering <b>104</b> attached to the frame <b>102</b>. <figref idref="DRAWINGS">FIG. <b>7</b></figref> shows the valve <b>100</b> engaged with a native tricuspid valve <b>10</b> between the right atrium and the right ventricle.

The frame <b>102</b> comprises a cellular structure that provides mechanical support for the shape and structures of the valve <b>100</b>. In some embodiments, the frame <b>102</b> is made from nitinol (NiTi), stainless steel, cobalt chromium, MP35N, titanium, polymeric materials, other biocompatible materials, or any combination thereof. Some or all parts of the frame <b>102</b> may be covered by the covering <b>104</b>. The frame <b>102</b> can be made of a laser cut, expanded, and shape-set material in some embodiments. The frame <b>102</b> is self-expanding in some embodiments. In some embodiments, the precursor material is tubular NiTi, a NiTi sheet, or other suitable types of precursor materials.

The covering <b>104</b> may made of a biocompatible polymer material (e.g., expanded polytetrafluoroethylene (ePTFE), UHMWPE (ultra-high molecular weight polyethylene), nylon, polyester (e.g., DACRON), or another synthetic material), natural tissues (e.g., bovine, porcine, ovine, or equine pericardium), or any combination thereof. The covering <b>104</b> can be attached to the frame <b>102</b> by suturing, using clips, adhesives, and/or any other suitable attachment process.

The valve <b>100</b> includes a main body <b>106</b>. The main body <b>106</b> includes an occluder <b>110</b> (e.g., a one-way valve) that defines a central axis <b>101</b>. The occluder <b>110</b> has flexible leaflets <b>111</b><i>a</i>, <b>111</b><i>b</i>, and <b>111</b><i>c </i>(collectively <b>111</b><i>a</i>-<i>c</i>) that cause the occluder <b>110</b> to function as a one-way valve (in a manner like a native tricuspid valve). The occluder <b>110</b> defines a circular inlet where the edges of leaflets <b>111</b><i>a</i>-<i>c </i>are attached to the frame <b>102</b>. Other side edges of the leaflets <b>111</b><i>a</i>-<i>c </i>are attached to posts <b>112</b><i>a</i>, <b>112</b><i>b</i>, and <b>112</b><i>c </i>of the frame <b>102</b>. The leaflets <b>111</b><i>a</i>-<i>c </i>also have distal free edges that are coaptable with each other to facilitate the opening and sealing of the occluder <b>110</b>.

The main body <b>106</b> of the valve <b>100</b> includes an inflow end portion <b>102</b><i>i</i>, a mid-body portion <b>102</b><i>m</i>, and an outflow end portion <b>1020</b>. The inflow end portion <b>102</b><i>i </i>includes a series of arch shapes in the frame <b>102</b>, circumscribing the axis <b>101</b> of the occluder <b>110</b>. The occluder leaflets <b>111</b><i>a</i>-<i>c </i>allow blood to directionally flow through the occluder <b>110</b> from the inflow end portion <b>102</b><i>i </i>to the outflow end portion <b>1020</b>. The leaflets <b>111</b><i>a</i>-<i>c </i>of the occluder <b>110</b> close against each other (e.g., coapt) to prevent blood flow in the other direction (to prevent blood flow from the outflow end portion <b>1020</b> to the inflow end portion <b>102</b><i>i</i>).

The embodiments of the valve <b>100</b> depicted in this disclosure employ three occluder leaflets <b>111</b><i>a</i>-<i>c</i>, which is referred to as tri-leaflet occluder. The occluder <b>110</b> of the valve <b>100</b> can optionally employ configurations other than a tri-leaflet occluder. For example, bi-leaflet, quad-leaflet, or mechanical valve constructs can be used in some embodiments. In particular implementations described herein, the flexible leaflets <b>111</b><i>a</i>-<i>c </i>are made of natural tissues such as porcine or bovine or equine or ovine pericardium. In such embodiments, the tissues are chemically cross-linked using glutaraldehyde or formaldehyde, or other aldehydes commonly used as crosslinking agents. In other embodiments, the flexible leaflets <b>111</b><i>a</i>-<i>c </i>are made of polymers such as polyurethane, polyester (DACRON) or expanded polytetrafluoroethylene (ePTFE). In some embodiments, the flexible leaflets <b>111</b><i>a</i>-<i>c </i>are attached to structural frame <b>102</b> using sutures that could be made of materials including but not limited to UHMWPE, nylon, or polyester (e.g., DACRON).

The valve <b>100</b> also includes a first anterior flap <b>120</b><i>a </i>(or septal anterior flap <b>120</b><i>a</i>), a second anterior flap <b>120</b><i>b </i>(or lateral anterior flap <b>120</b><i>b</i>), and at least one posterior flap <b>130</b>. The frame <b>102</b> and the covering <b>104</b> combine to form the anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b>. The frame <b>102</b> provides the structure of the anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b>, and the covering <b>104</b> provides occlusion. While the depicted embodiment includes two anterior flaps <b>120</b><i>a</i>-<i>b</i>, in some embodiments one, three, four, or more than four anterior flaps can be included. While the depicted embodiment includes a single posterior flap <b>130</b>, in some embodiments two, three, four, or more than four posterior flaps can be included.

The anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b> extend away from the outflow end portion <b>1020</b> of the main body <b>106</b> in opposite directions away from the axis <b>101</b>. That is, the posterior flap <b>130</b> extends directionally opposite from the extension direction of the first and second anterior flaps <b>120</b><i>a</i>-<i>b</i>. In some embodiments, the posterior flap <b>130</b> extends 180° opposite from the extension direction of the first and second anterior flaps <b>120</b><i>a</i>-<i>b</i>. In particular embodiments, the anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b> extend away from the outflow end portion <b>1020</b> of the main body <b>106</b> transverse to the axis <b>101</b> of the occluder <b>110</b>.

In the depicted embodiment, the first anterior flap <b>120</b><i>a </i>and the second anterior flap <b>120</b><i>b </i>each include a mid-body portion <b>124</b> (<figref idref="DRAWINGS">FIG. <b>6</b></figref>) that is bent at an angle so as to direct terminal end portions of the anterior flaps <b>120</b><i>a</i>-<i>b </i>toward the inlet end of the main body <b>106</b>. In some embodiments, the anterior flaps <b>120</b><i>a</i>-<i>b </i>initially extend away from the main body <b>106</b> substantially perpendicularly (e.g., within about 80° to) 100° to the central axis <b>101</b>. Then, at the mid-body portion <b>124</b>, the anterior flaps <b>120</b><i>a</i>-<i>b </i>have a bend that defines an angle θ in a range of between 20° to 60°, or 30° to 60°, or 30° to 70°, or 40° to 60°, or 40° to 70°, or 40° to 50°, without limitation.

The bends in the mid-body <b>106</b> of the anterior flaps <b>120</b><i>a</i>-<i>b </i>can allow the anterior flaps <b>120</b><i>a</i>-<i>b </i>to conform to the contours of the wall that defines the RVOT (as shown in <figref idref="DRAWINGS">FIG. <b>5</b></figref>). Accordingly, the bent anterior flaps <b>120</b><i>a</i>-<i>b </i>can reduce the potential of the anterior flaps <b>120</b><i>a</i>-<i>b </i>to restrict blood flow through the RVOT in some cases.

In some patients, the shape of the annulus of the native tricuspid valve is not planar. For example, in some patients the native annulus is “saddle-shaped.” Accordingly, in order to provide enhanced sealing between the valve <b>100</b> and the native annulus for such anatomies, in the depicted embodiment the main body <b>106</b> is made longitudinally longer (where the “length” aspect is defined along the axis <b>101</b>) in certain areas to correspond with a non-planar saddle-shaped native annulus. In the depicted embodiment, as shown in <figref idref="DRAWINGS">FIGS. <b>4</b> and <b>5</b></figref>, there are at least two cells <b>102</b><i>a </i>and <b>102</b><i>b </i>(on the lateral and septal sides of the frame <b>102</b>, so at least four cells in total) that extend farther into the right ventricle than the other cells of the frame <b>102</b>. The end portion locations of those two cells <b>102</b><i>a</i>-<i>b </i>(on each side of the frame <b>102</b>) correspond to the lower areas (toward the ventricle) of the saddle-shaped native annulus.

In some embodiments, the two cells <b>102</b><i>a</i>-<i>b </i>extend farther into the ventricle than any other portion of the valve <b>100</b>. If the inflow end portion <b>102</b><i>i </i>is defined as the superior end of the valve <b>100</b> and the outflow end portion <b>1020</b> is defined as the inferior end of the valve <b>100</b>, it can be said that the two cells <b>102</b><i>a</i>-<i>b </i>extend farther inferiorly than any other part of the valve <b>100</b> including, for example, the second portion <b>130</b><i>b </i>of the posterior flap <b>130</b>.

Still referring to <figref idref="DRAWINGS">FIGS. <b>4</b>-<b>6</b></figref>, in the depicted embodiment, the valve <b>100</b> includes one or more optional suture knots <b>105</b>. The suture knots <b>105</b> can be comprised of suture thread material (e.g., ligature thread material) that is bunched together in a knotted form. The suture knots <b>105</b> are located on the exterior surface of the covering <b>104</b>. Accordingly, the suture knots <b>105</b> are small protrusions that provide supplemental migration resistance to help maintain the valve <b>100</b> in a desired position relative to the native anatomy (e.g., relative to the annulus of the native tricuspid valve).

In some embodiments, the suture knots <b>105</b> are made of the same suture thread material that is used to attach the covering <b>104</b> to the frame <b>102</b>. Accordingly, as in the depicted embodiment, the suture knots <b>105</b> can be located along the elongate members of the frame <b>102</b>. However, such placement of the suture knots <b>105</b> is optional. The suture knots <b>105</b> can be located anywhere on the valve <b>100</b>, and in any desired numbers. In the depicted embodiment, the suture knots are located on the inferior lateral surfaces of the valve <b>100</b> (on the outflow end portion <b>1020</b>) between the anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b> of the valve <b>100</b>. Alternatively or additionally, in some embodiments suture knots <b>105</b> can be located on other external surface areas of the valve <b>100</b>.

As shown in <figref idref="DRAWINGS">FIG. <b>6</b></figref>, the depicted embodiment includes an opening <b>126</b><i>a </i>that is defined by the covering <b>104</b> located at a terminal end portion of the first anterior flap <b>120</b><i>a</i>. Additionally, the covering <b>104</b> on the second anterior flap <b>120</b><i>b </i>defines an opening <b>126</b><i>b </i>at a terminal end portion of the second anterior flap <b>120</b><i>b. </i>

The openings <b>126</b><i>a</i>-<i>b </i>in the end portions of the anterior flaps <b>120</b><i>a</i>-<i>b </i>allow blood to flow through the anterior flaps <b>120</b><i>a</i>-<i>b </i>(via the openings <b>126</b><i>a</i>-<i>b</i>). This can be beneficial because in some implementations the anterior flaps <b>120</b><i>a</i>-<i>b </i>extend into the RVOT. Accordingly, such openings <b>126</b><i>a</i>-<i>b </i>may in some cases reduce the potential of the anterior flaps <b>120</b><i>a</i>-<i>b </i>to restrict blood flow through the RVOT.

In the depicted embodiment, the posterior flap <b>130</b> includes a first portion <b>130</b><i>a </i>and a second portion <b>130</b><i>b </i>that are arranged at an angle in relation to each other. The first portion <b>130</b><i>a </i>extends away from the outflow end portion <b>1020</b> of the main body <b>106</b> generally transverse to the axis <b>101</b> of the occluder <b>110</b>. The second portion <b>130</b><i>b </i>of the posterior flap <b>130</b> extends from the first portion <b>130</b><i>a</i>. In the depicted embodiment, the second portion <b>130</b><i>b </i>extends generally parallel to the axis <b>101</b> of the occluder <b>110</b>. The angle defined between the first portion <b>130</b><i>a </i>and the second portion <b>130</b><i>b </i>can be in a range of 80° to 100°, or 70° to 110°, or 60° to 120°, or 50° to 130°, or 40° to 140°, without limitation.

The first anterior flap <b>120</b><i>a </i>and the second anterior flap <b>120</b><i>b </i>each extend in the same direction, which is opposite of the direction that the posterior flap <b>130</b> extends. In the depicted embodiment, portions of the first anterior flap <b>120</b><i>a </i>and the second anterior flap <b>120</b><i>b </i>overlap each other. An advantage of having the two separate anterior flaps <b>120</b><i>a</i>-<i>b </i>(rather than a single larger anterior flap) is that the anterior flap portion of the valve <b>100</b> can be radially compressed to a smaller profile for transcatheter delivery by the virtue of having the two separate anterior flaps <b>120</b><i>a</i>-<i>b </i>(as compared to having a single larger anterior flap).

In some embodiments, as shown in <figref idref="DRAWINGS">FIG. <b>5</b></figref>, the first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>extend into the RVOT and overlap one axially on top of the other. This arrangement is functionally akin to a cantilevered beam arrangement. With the first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>overlapping on each other, the bending resistance of the combination of the first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>is increased (as compared to a single flap or non-overlapping flaps). This arrangement enables an advantageous extent of rigidity, without having to use framework members that are larger in cross-section. That is, the overlapping arrangement of the first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>allow for the use of smaller framework members, which in turn importantly allows for a smaller collapsed delivery size (diameter). In other words, overlapping arrangement of the first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>provides a support structure that is thicker without having to use a material with higher wall thickness (from which the framework is created); ultimately providing the bending stiffness or rigidity that keeps the valve <b>100</b> stable when RV pressure acts on the valve <b>100</b>.

In the depicted embodiment, an open passage <b>122</b> is defined between the first anterior flap <b>120</b><i>a </i>and the second anterior flap <b>120</b><i>b</i>. The open passage <b>122</b> can be used, for example, for passing a pacemaker lead through the valve <b>100</b>, without disturbing the functioning of the occluder <b>110</b>. Accordingly, the valve <b>100</b> can facilitate the pass-through of the pacemaker lead while still providing sealing to prevent tricuspid valve regurgitation from the RV to the RA. In some cases, the pacemaker lead is pre-existing and the valve <b>100</b> is implanted subsequently (with the open passage <b>122</b> being used to receive the pacemaker lead). In other cases, the valve <b>100</b> can be pre-existing and the pacemaker lead can be subsequently passed through the open passage <b>122</b>. This could take place both during the same implant procedure, or as a subsequent procedure.

Still referring to <figref idref="DRAWINGS">FIGS. <b>4</b>-<b>6</b></figref>, in some embodiments the valve <b>100</b> also includes one or more leaflet engagement members <b>140</b>. In the depicted embodiment, the valve <b>100</b> includes two leaflet engagement members: a first leaflet engagement member <b>140</b><i>a </i>and a second engagement member <b>140</b><i>b</i>. In the depicted embodiment, the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>extend from the outflow end portion <b>1020</b> of the main body <b>106</b>. In some embodiments, the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>extend from the mid-body portion <b>102</b><i>m </i>of the main body <b>106</b>.

The leaflet engagement members <b>140</b><i>a</i>-<i>b </i>extend from the frame <b>102</b> and bend toward the inflow end portion <b>102</b><i>i </i>of the main body <b>106</b>. In other words, a portion of each leaflet engagement member <b>140</b><i>a</i>-<i>b </i>extends toward the inflow end portion <b>102</b><i>i </i>of the main body <b>106</b>. A space, groove, or slot is defined between the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>and the outer surface of the frame <b>102</b> (with the covering <b>104</b> being present on the frame <b>102</b> and leaflet engagement members <b>140</b><i>a</i>-<i>b</i>). As described further below, the space, groove, or slot receives and mechanically captures/holds a portion of a native leaflet (e.g., the posterior leaflet <b>11</b><i>p </i>and/or the septal leaflet <b>11</b><i>s</i>) to provide migration resistance for the valve <b>100</b>.

In the depicted embodiment, the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>extend from the frame <b>102</b> of the main body <b>106</b> in the same direction as the posterior flap <b>130</b>. The posterior flap <b>130</b> extends away from the main body <b>106</b> farther than the leaflet engagement members <b>140</b><i>a</i>-<i>b</i>. Various other arrangements of the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b> are also envisioned and within the scope of this disclosure.

The leaflet engagement members <b>140</b><i>a</i>-<i>b </i>may be U-shaped wire loops, as in the depicted embodiment. The wire loops that make up the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>can be continuous with the wire members of the frame <b>102</b>.

In the depicted embodiment, the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>terminate at free ends. Accordingly, the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>point toward the inflow end portion <b>102</b><i>i </i>of the main body <b>106</b>, with the free ends of the leaflet engagement members <b>140</b><i>a</i>-<i>b </i>being the closest to the inflow end portion <b>102</b><i>i</i>. This arrangement defines the space, groove, or slot receives and mechanically captures/holds a portion of a native leaflet to provide migration resistance for the valve <b>100</b>.

The depicted embodiment of the valve <b>100</b> includes an optional posterior arm <b>150</b>. The posterior arm <b>150</b> comprises a wire member (e.g., an elongated loop) that extends from the frame <b>102</b> and includes a free end <b>150</b><i>e </i>(which can also be said to be located at a distal end portion of the posterior arm <b>150</b>). In some embodiments, the posterior arm <b>150</b> is a wire member that is constructed unitarily with wire members of the frame <b>120</b>. Hence, it can be said that the posterior arm <b>150</b> is a portion of the frame <b>120</b>. In the depicted embodiment, the covering <b>104</b> is attached to the posterior arm <b>150</b>, including the free end <b>150</b><i>e. </i>

In the depicted embodiment, the posterior arm <b>150</b> extends from the inflow end portion <b>102</b><i>i </i>of the frame <b>102</b>. The posterior arm <b>150</b> extends in a direction that is the same as, or that is generally (e.g., +/−20°) parallel to, the direction in which the posterior flap <b>130</b> extends. In some embodiments, the posterior arm <b>150</b> extends from the mid-body portion <b>102</b><i>m </i>of the frame <b>102</b>. The location of the free end <b>150</b><i>e </i>is within a transverse plane (e.g., taken perpendicular to the axis <b>101</b>) that intersects the mid-body portion <b>102</b><i>m </i>of the frame <b>102</b> or the inflow end portion <b>102</b><i>i </i>of the frame <b>102</b>.

The posterior arm <b>150</b> provides additional anchorage and migration resistance for the valve <b>100</b>. As depicted in <figref idref="DRAWINGS">FIG. <b>5</b></figref>, the free end <b>150</b><i>e </i>of the posterior arm <b>150</b> abuts against an anatomical structure when the valve <b>100</b> is engaged in a native tricuspid valve <b>10</b>. In some cases, the free end <b>150</b><i>e </i>of the posterior arm <b>150</b> abuts against an interior wall of an inferior vena cava, or coronary sinus, or the right atrium, or another anatomical structure. Where it abuts can be largely a function of the variable anatomy from patient to patient. The migration resistance provided by the posterior arm <b>150</b> can be particularly advantageous during diastole when the occluder <b>110</b> is open to allow blood flow from the right atrium to the right ventricle via the occluder <b>110</b>.

Referring also to <figref idref="DRAWINGS">FIG. <b>7</b></figref>, in some embodiments the frame <b>102</b> can include an anterior arm <b>160</b>. The anterior arm <b>160</b> may also be covered similarly to the posterior arm <b>150</b>. The anterior arm <b>160</b> comprises a wire member (e.g., an elongated loop) that extends from the frame <b>102</b> and includes a free end <b>160</b><i>e </i>(which can also be said to be located at a distal end portion of the posterior arm <b>160</b>). In some embodiments, the anterior arm <b>160</b> is a wire member that is constructed unitarily with wire members of the frame <b>120</b>. Hence, it can be said that the anterior arm <b>160</b> is a portion of the frame <b>120</b>. In the depicted embodiment, the covering <b>104</b> is attached to the anterior arm <b>160</b>, including the free end <b>160</b><i>e. </i>

In the depicted embodiment, the anterior arm <b>160</b> extends from the inflow end portion <b>102</b><i>i </i>of the frame <b>102</b>. The anterior arm <b>160</b> extends in an anterior direction away from the axis <b>101</b> (e.g., a direction that is generally the same as the direction in which the anterior flaps <b>120</b><i>a</i>-<i>b </i>extend). In some embodiments, the anterior arm <b>160</b> extends from the mid-body portion <b>102</b><i>m </i>of the frame <b>102</b>. The location of the free end <b>160</b><i>e </i>is within a transverse plane (e.g., taken perpendicular to the axis <b>101</b>) that intersects the mid-body portion <b>102</b><i>m </i>of the frame <b>102</b> or the inflow end portion <b>102</b><i>i </i>of the frame <b>102</b>.

The anterior arm <b>160</b> provides additional anchorage and migration resistance for the valve <b>100</b>. The free end <b>160</b><i>e </i>of the anterior arm <b>160</b> abuts against an anatomical structure when the valve <b>100</b> is engaged in a native tricuspid valve <b>10</b>. In some cases, the free end <b>160</b><i>e </i>of the anterior arm <b>160</b> abuts against an interior wall of a right atrial appendage or another anatomical structure. Where the anterior arm <b>160</b> lands relative to the anatomy can vary based on patient to patient variability. The migration resistance provided by the anterior arm <b>160</b> can be particularly advantageous during diastole when the occluder <b>110</b> is open to allow blood flow from the right atrium to the right ventricle via the occluder <b>110</b>.

Some embodiments of the valve <b>100</b> include the posterior arm <b>150</b>, but not the anterior arm <b>160</b>. Other embodiments of the valve <b>100</b> include the anterior arm <b>160</b>, but not the posterior arm <b>150</b>. Still other embodiments of the valve <b>100</b> include both the posterior arm <b>150</b> and the anterior arm <b>160</b>.

In some embodiments, such as the depicted embodiment (e.g., as best visible in <figref idref="DRAWINGS">FIG. <b>7</b></figref>), the septal and lateral edge portions of the anterior flaps <b>120</b><i>a</i>-<i>b </i>can include a strut framework to provide additional structural sturdiness to the anterior flaps <b>120</b><i>a</i>-<i>b</i>. In particular, the first anterior flap <b>120</b><i>a </i>includes a septal anterior strut framework <b>128</b><i>a</i>, and the second anterior flap <b>120</b><i>b </i>includes a lateral anterior strut framework <b>128</b><i>b</i>. As depicted in <figref idref="DRAWINGS">FIG. <b>7</b></figref>, in some embodiments the strut members of the septal anterior strut framework <b>128</b><i>a </i>can be “S-shaped,” and the strut members of the lateral anterior strut framework <b>128</b><i>b </i>can be “L-shaped.” This distinction between the septal anterior strut framework <b>128</b><i>a </i>and the lateral anterior strut framework <b>128</b><i>b </i>can provide the clinician with a visual indication of the orientation of the valve <b>100</b> while various visualization modalities (e.g., x-ray fluoroscopy) is/are being used during the deployment of the valve <b>100</b>.

<figref idref="DRAWINGS">FIGS. <b>8</b> and <b>9</b></figref> illustrate more details of the example prosthetic heart valve deployment system <b>200</b> (or “valve deployment system <b>200</b>” or simply “deployment system <b>200</b>”). The deployment system <b>200</b> includes the control handle <b>210</b>, an outer sheath catheter <b>220</b>, a middle deflectable catheter <b>230</b>, and an inner control catheter <b>240</b>. The outer sheath catheter <b>220</b> defines a first lumen. The middle deflectable catheter <b>230</b> is slidably disposed in the first lumen and defines a second lumen. The inner control catheter <b>240</b> is slidably disposed in the second lumen. A clinician user can control the positions, relative to each other, of the outer sheath catheter <b>220</b>, the middle deflectable catheter <b>230</b>, and the inner control catheter <b>240</b> by manipulating the control handle <b>210</b>.

In some embodiments, the outer sheath catheter <b>220</b> is selectively deflectable or steerable. That is, in some embodiments a clinician can controllably steer or deflect a distal end portion of the outer sheath catheter <b>220</b> during the deployment process of the valve <b>100</b>. This steerability of the outer sheath catheter <b>220</b> can be beneficial to the clinician when navigating the patient's anatomy and/or during the actual valve release or retrieval processes in the patient's heart.

The inner control catheter <b>240</b> includes a curved portion <b>242</b>. The curved portion <b>242</b> is elastically deformable. That is, while the curved portion <b>242</b> is located within the confines of the first lumen of the outer sheath catheter <b>220</b>, the curved portion <b>242</b> is essentially linear (or at least more linear than when the curved portion <b>242</b> is radially unconstrained). When the curved portion <b>242</b> of the inner control catheter <b>240</b> is distally expressed out (either by pushing the inner control catheter <b>240</b> distally or by pulling the outer sheath catheter <b>220</b> proximally) from the confines of the first lumen of the outer sheath catheter <b>220</b>, the curved portion <b>242</b> then naturally elastically reconfigures to exhibit a pronounced curve (e.g., as shown in <figref idref="DRAWINGS">FIG. <b>11</b></figref>). Thus, it can be said that the natural shape, or unconstrained shape, of the inner control catheter <b>240</b> includes the curved portion <b>242</b> that defines an interior angle. In some embodiments, the interior angle can be between 130° and 160°, or between 120° and 150°, or between 110° and 140°, or between 100° and 130°, or between 90° and 120°, or between 80° and 110°, or between 80° and 100°, without limitation. In some embodiments, the interior angle can be less than 160°, or less than 150°, or less than 140°, or less than 135°, or less than 130°, or less than 120°, or less than 110°, or less than 100°, or less than 90° without limitation.

The middle deflectable catheter <b>230</b> includes a selectively deflectable distal end portion with at least one plane of deflection. In some embodiments, the selectively deflectable distal end portion is deflectable in two planes. In some embodiments, the middle deflectable catheter <b>230</b> includes two or more separate selectively deflectable portions that are in same planes or in different planes. A clinician user can control the extent of deflection of the selectively deflectable distal end portion of the middle deflectable catheter <b>230</b> by manipulating an actuator of the control handle <b>210</b>.

In the depicted embodiment, the selectively deflectable distal end portion can be selectively deflectable in a same plane as the plane of the curved portion <b>242</b> of the inner control catheter <b>240</b>. Accordingly, when the selectively deflectable distal end portion of the middle deflectable catheter <b>230</b> is deflected by a clinician user, the curvature of the combination of the middle deflectable catheter <b>230</b> and the inner control catheter <b>240</b> in relation to the axis of the outer sheath catheter <b>220</b> is increased beyond that of the interior angle of the inner control catheter <b>240</b> alone. In some embodiments, the combined curvature of the middle deflectable catheter <b>230</b> and the inner control catheter <b>240</b> in relation to the axis of the outer sheath catheter <b>220</b> can define an interior angle between 90° and 110°, or between 80° and 100°, or between 70° and 90°, or between 60° and 80°, or between 50° and 70°, or between 30° and 60°, or between 0° and 30°, without limitation. This high degree of curvature can be beneficial during deployment of a prosthetic valve (such as the valve <b>100</b>) using the deployment system <b>200</b>, as described further below.

The inner control catheter <b>240</b> can also include mechanical features for releasably coupling with a prosthetic valve (such as, but not limited to, the valve <b>100</b>; see <figref idref="DRAWINGS">FIGS. <b>4</b>-<b>7</b></figref>). For example, in the depicted embodiment, the inner control catheter <b>240</b> includes one or more control wires and/or release pins that can releasably couple a prosthetic valve (e.g., the valve <b>100</b>) to the inner control catheter <b>240</b> in a low profile delivery configuration for transcatheter, trans-vascular deployment at a native heart valve location of a patient.

In the depicted embodiment (e.g., as seen in <figref idref="DRAWINGS">FIG. <b>9</b></figref>), the valve deployment system <b>200</b> includes a first control wire <b>243</b>, a second control wire <b>244</b>, a third control wire <b>245</b>, a fourth control wire <b>246</b>, and a fifth control wire <b>247</b>. The control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> are each individually controllable by a clinician user at the control handle <b>210</b> (as described further below).

The control wires <b>243</b>, <b>244</b>, and <b>246</b> are each wire loops. That is, each of the control wires <b>243</b>, <b>244</b>, and <b>246</b> has two free ends that are located at the control handle <b>210</b>. The control wires <b>243</b>, <b>244</b>, and <b>246</b> each extend continuously between their two free ends, thereby forming the loops as shown in <figref idref="DRAWINGS">FIG. <b>9</b></figref>. The loops releasably couple with particular portions of the prosthetic heart valve, as described further below (e.g., <figref idref="DRAWINGS">FIGS. <b>13</b> and <b>14</b></figref>).

When a clinician user applies tension to the looped control wires <b>243</b>, <b>244</b>, and <b>246</b> at the control handle <b>210</b>, the respective wire loop (and the respective portions of the prosthetic heart valve to which the control wires <b>243</b>, <b>244</b>, and <b>246</b> are coupled) are drawn radially closer to the inner control catheter <b>240</b>. When a clinician user relaxes the tension of the control wires <b>243</b>, <b>244</b>, and <b>246</b> (e.g., individually distally feeds out or pays out the control wires <b>243</b>, <b>244</b>, and <b>246</b>) the respective portions of the prosthetic heart valve to which the control wires <b>243</b>, <b>244</b>, and <b>246</b> are each coupled are allowed to radially self-expand away from the inner control catheter <b>240</b>.

A clinician user can fully uncouple the looped control wires <b>243</b>, <b>244</b>, and <b>246</b> from the prosthetic heart valve by proximally pulling one free end portion of the respective looped control wire <b>243</b>, <b>244</b>, or <b>246</b> (and continuing such proximal pulling) until the other free end portion is fully pulled out of engagement with the prosthetic heart valve.

In contrast to the looped control wires <b>243</b>, <b>244</b>, and <b>246</b>, the control wires <b>245</b> and <b>247</b> (which can also be referred to as “release pins”) do not comprise wire loops. Instead, the control wires <b>245</b> and <b>247</b> each have a first free end at the control handle <b>210</b> and a second free end that distally terminates at a respective location at the distal end portion of the deployment system <b>200</b>.

Like the looped control wires <b>243</b>, <b>244</b>, and <b>246</b>, the control wires <b>245</b> and <b>247</b> are each coupled with a particular portion of the prosthetic heart valve. For example, at the distal end portion of the deployment system <b>200</b>, the third control wire <b>245</b> is coupled with a portion of the prosthetic heart valve (as described in reference to <figref idref="DRAWINGS">FIGS. <b>13</b> and <b>14</b></figref>). The third control wire <b>245</b> then releasably terminates at the distal tip member <b>241</b> of the inner catheter <b>240</b>. Similarly, the fifth control wire <b>247</b>, at the distal end portion of the deployment system <b>200</b>, is coupled with a portion of the prosthetic heart valve (as described in reference to <figref idref="DRAWINGS">FIGS. <b>13</b> and <b>14</b></figref>). The fifth control wire <b>247</b> then releasably terminates at a distal collar <b>231</b> of the deflectable catheter <b>230</b>.

When the control wires <b>245</b> and <b>247</b> are pulled proximally (individually), their respective distally-located free ends uncouple from the distal tip member <b>241</b> or the distal collar <b>231</b>, respectively. In addition, when the control wires <b>245</b> and <b>247</b> are pulled proximally (individually), the respective portion of the prosthetic heart valve to which the control wires <b>245</b> and <b>247</b> are releasably coupled are released from their detainment by the control wires <b>245</b> and <b>247</b> and are allowed to self-expand to their natural configuration.

As shown in the various cross-sectional views of the inner catheter <b>240</b> in <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>12</b></figref>, the control wires <b>243</b>, <b>244</b>, <b>245</b>, and <b>246</b> are each slidably disposed in lumens defined by the wall of the inner catheter <b>240</b>. <figref idref="DRAWINGS">FIG. <b>10</b></figref> is taken at the cut plane <b>12</b>-<b>12</b> shown in <figref idref="DRAWINGS">FIG. <b>9</b></figref>. Accordingly, <figref idref="DRAWINGS">FIG. <b>10</b></figref> shows each of the control wires <b>243</b>, <b>244</b>, <b>245</b>, and <b>246</b>. Shortly after the cut plane <b>12</b>-<b>12</b> (moving distally), the first control wire <b>243</b> exits the lumens of the inner catheter <b>240</b> to form the loop shown in <figref idref="DRAWINGS">FIG. <b>9</b></figref>. Accordingly, in <figref idref="DRAWINGS">FIG. <b>11</b></figref> (taken at the cut plane <b>13</b>-<b>13</b> of <figref idref="DRAWINGS">FIG. <b>9</b></figref>) the first control wire <b>243</b> is no longer seen. Instead, only the control wires <b>244</b>, <b>245</b>, and <b>246</b> are seen. Shortly after the cut plane <b>13</b>-<b>13</b> (moving distally), the second control wire <b>244</b> exits the lumens of the inner catheter <b>240</b> to form the loop shown in <figref idref="DRAWINGS">FIG. <b>9</b></figref>. Accordingly, in <figref idref="DRAWINGS">FIG. <b>12</b></figref> (taken at the cut plane <b>14</b>-<b>14</b> of <figref idref="DRAWINGS">FIG. <b>9</b></figref>) the second control wire <b>244</b> is no longer seen. Instead, only the control wires <b>245</b> and <b>246</b> are seen. Shortly after the cut plane <b>14</b>-<b>14</b> (moving distally), the fourth control wire <b>246</b> exits the lumens of the inner catheter <b>240</b> to form the loop shown in <figref idref="DRAWINGS">FIG. <b>9</b></figref>. The third control wire <b>245</b> continues distally and terminates at the distal tip member <b>241</b> of the inner catheter <b>240</b>. The fifth control wire <b>247</b> is not seen in <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>12</b></figref> because it distally terminates at the distal collar <b>231</b> of the deflectable catheter <b>230</b> (prior to the proximal-most cut plane <b>12</b>-<b>12</b>).

<figref idref="DRAWINGS">FIGS. <b>13</b> and <b>14</b></figref> illustrate how the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> can be releasably coupled to respective portions of the prosthetic heart valve <b>100</b>. In some embodiments, the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> are releasably coupled with the wire elements of the frame <b>102</b>. In some embodiments, an additional member (such as a suture loop, a ring, etc.) is used to releasably couple one or more of the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> to the particular portions of the prosthetic heart valve <b>100</b>.

As shown in <figref idref="DRAWINGS">FIG. <b>13</b></figref>, the first control wire <b>243</b> can be releasably coupled to the inflow end <b>102</b><i>i </i>of the main body <b>106</b>. In particular, the first control wire <b>243</b> can be arranged in a loop and releasably coupled around the perimeter of the inflow end <b>102</b><i>i</i>. When tensioned, the first control wire <b>243</b> can cinch the inflow end <b>102</b><i>i </i>radially inward toward the inner control catheter <b>240</b> like a lasso or a purse string.

As shown in <figref idref="DRAWINGS">FIG. <b>14</b></figref>, the second control wire <b>244</b> can be releasably coupled to the outflow end <b>1020</b> of the main body <b>106</b>. In particular, the second control wire <b>244</b> can be arranged in a loop and releasably coupled around the perimeter of the outflow end <b>1020</b>. When tensioned, the second control wire <b>244</b> can cinch the outflow end <b>1020</b> radially inward toward the inner control catheter <b>240</b> like a lasso or a purse string.

The third control wire <b>245</b> is configured as a release pin that can be releasably coupled to the anterior flap <b>120</b><i>a </i>and/or the anterior flap <b>120</b><i>b </i>of the prosthetic heart valve <b>100</b>. The third control wire <b>245</b> simply extends through the anterior flap <b>120</b><i>a </i>and/or the anterior flap <b>120</b><i>b </i>and then releasably terminates at the distal tip member <b>241</b>. The third control wire <b>245</b> is held closely adjacent to the distal tip member <b>241</b> by the structure of the distal tip member <b>241</b>. The third control wire <b>245</b> thereby holds the anterior flap <b>120</b><i>a </i>and/or the anterior flap <b>120</b><i>b </i>close to the distal tip member <b>241</b>.

The fourth control wire <b>246</b> is a wire loop that can be releasably coupled to the posterior flap <b>130</b>. When tensioned, the fourth control wire <b>246</b> can pull the posterior flap <b>130</b> radially inward toward the inner control catheter <b>240</b> like a snare.

The fifth control wire <b>247</b> is configured as a release pin that can be releasably coupled to the posterior arm <b>150</b> of the prosthetic heart valve <b>100</b>. For example, the fifth control wire <b>247</b> can simply extend through the free end <b>150</b><i>e </i>of the posterior arm <b>150</b> and then releasably terminate at the distal collar <b>231</b> of the middle deflectable catheter <b>230</b>. The tension of the fifth control wire <b>247</b> holds the fifth control wire <b>247</b> closely adjacent to the middle deflectable catheter <b>230</b>. The fifth control wire <b>247</b> thereby holds the posterior arm <b>150</b> close to the middle deflectable catheter <b>230</b> while the fifth control wire <b>247</b> is in tension.

<figref idref="DRAWINGS">FIG. <b>15</b></figref> shows the prosthetic heart valve <b>100</b> releasably coupled to the middle deflectable catheter <b>230</b> and the inner control catheter <b>240</b> by the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> (in this view the control wires <b>243</b> and <b>244</b> are not visible). The posterior flap <b>130</b> is shown in a partially expanded orientation (e.g., with the tension of the fourth control wire <b>246</b> partially relaxed). During the initial delivery process of the prosthetic heart valve <b>100</b> the posterior flap <b>130</b> would be drawn in and held more closely radially inward to the inner catheter <b>240</b> than the depicted orientation.

<figref idref="DRAWINGS">FIG. <b>16</b></figref> shows a schematic illustration of the valve <b>100</b>. <figref idref="DRAWINGS">FIG. <b>17</b></figref> schematically shows the valve <b>100</b> coupled to the inner control catheter <b>240</b> and located within the first lumen defined by the outer sheath catheter <b>220</b>. The distal tip of the middle deflectable catheter <b>230</b> is also visible. In this arrangement, the valve <b>100</b> is radially compressed to a low-profile delivery configuration while within the outer sheath catheter <b>220</b>. In some embodiments, the valve <b>100</b> (or portions thereof are wrapped or folded around the inner control catheter <b>240</b>. For example, in some embodiments the anterior flaps <b>120</b><i>a</i>-<i>b </i>are wrapped around the inner control catheter <b>240</b>. The valve <b>100</b> can tend to try to self-expand as it emerges from the outer sheath catheter <b>220</b> (e.g., by the manual retraction of the outer sheath catheter <b>220</b> relative to the middle deflectable catheter <b>230</b> and the inner control catheter <b>240</b>). However, during the deployment process, the clinician user can controllably expand and/or release the particular portions of the valve <b>100</b> to which the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> are releasably coupled.

In some embodiments, when the valve <b>100</b> is in its collapsed delivery configuration within the outer sheath catheter <b>220</b>, the portions of the valve <b>100</b> are arranged relative to each other as follows. The first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>(which can be wrapped on each other) are distal-most. The posterior arm <b>150</b> is proximal-most within the outer sheath catheter <b>220</b>. The occluder portion (or valve core) <b>110</b> with the flexible leaflets is the next proximal-most. The posterior anchoring flap <b>130</b> is arranged between the distal-most first and second anterior flaps <b>120</b><i>a</i>-<i>b </i>and the occluder portion <b>110</b>.

The control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> can be tensioned to draw and maintain the associated portions of the valve <b>100</b> radially inward to be snug against the inner control catheter <b>240</b>. During deployment of the valve <b>100</b>, the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b> can be individually relaxed and then released to allow the associated portion of the valve <b>100</b> to expand elastically toward its natural expanded shape.

Still referring to <figref idref="DRAWINGS">FIG. <b>17</b></figref>, in this delivery configuration the curved portion <b>242</b> of the inner control catheter <b>240</b> is being constrained in an essentially linear configuration by the outer sheath catheter <b>220</b>. However, when the inner control catheter <b>240</b> is expressed from the outer sheath catheter <b>220</b> (or as the outer sheath catheter <b>220</b> is pulled proximally relative to the inner control catheter <b>240</b>), the curved portion <b>242</b> will become unconstrained and will elastically deflect to its natural curved configuration (e.g., as shown in <figref idref="DRAWINGS">FIG. <b>15</b></figref>). The curved configuration of the curved portion <b>242</b> is beneficial for the deployment process of the valve <b>100</b> into engagement with a native tricuspid valve <b>10</b>, as described further below.

<figref idref="DRAWINGS">FIG. <b>18</b></figref> shows the control handle <b>210</b> in more detail. The control handle <b>210</b> includes: (i) a first control wire tension adjustment mechanism <b>211</b><i>a </i>and <b>212</b><i>a </i>(which is used by a clinician user to control the tension of the first control wire <b>243</b>), (ii) a second control wire tension adjustment mechanism <b>211</b><i>b </i>and <b>212</b><i>b </i>(which is used by the clinician user to control the tension of the second control wire <b>244</b>), and (iii) a third control wire tension adjustment mechanism <b>211</b><i>c </i>and <b>212</b><i>c </i>(which is used by the clinician user to control the tension of the fourth control wire <b>246</b>).

The control handle <b>210</b> also includes a first control wire release handle <b>214</b> (which is used by the clinician user to pull the third control wire <b>245</b> proximally to release the one or more anterior flaps <b>120</b><i>a/b</i>). The first control wire release handle <b>214</b> is fixedly attached to the proximal free end of the third control wire <b>245</b> and releasably attached to the control handle <b>210</b>. To pull the third control wire <b>245</b> proximally to release the one or more anterior flaps <b>120</b><i>a/b</i>, the first control wire release handle <b>214</b> can be detached from the control handle <b>210</b> and then used to pull the third control wire <b>245</b> proximally.

The control handle <b>210</b> also includes a steering actuator <b>216</b> (which is used by the clinician user to selectively deflect or steer the deflectable distal end portion <b>232</b> of the deflectable catheter <b>230</b>).

The control handle <b>210</b> also includes a second control wire release handle <b>218</b> (which is used by the clinician user to pull the fifth control wire <b>247</b> proximally to release the posterior arm <b>150</b>). The second control wire release handle <b>218</b> is fixedly attached to the proximal free end of the fifth control wire <b>247</b> and releasably attached to the control handle <b>210</b>. To pull the fifth control wire <b>247</b> proximally to release the posterior arm <b>150</b>, the second control wire release handle <b>218</b> can be detached from the control handle <b>210</b> and then used to pull the fifth control wire <b>247</b> proximally.

<figref idref="DRAWINGS">FIGS. <b>19</b> and <b>20</b></figref> illustrate the manner in which the three control wire tension adjustment mechanisms of the control handle <b>210</b> can be individually manipulated by the clinician user to control the tension and release of the control wires <b>243</b>, <b>244</b>, and <b>246</b> that are configured in loops. The first control wire tension adjustment mechanism <b>211</b><i>a </i>and <b>212</b><i>a</i>, and the first control wire <b>243</b> are used in the depicted example. The other two control wire tension adjustment mechanisms can be operated in the same manner

A comparison of <figref idref="DRAWINGS">FIG. <b>19</b></figref> and <figref idref="DRAWINGS">FIG. <b>20</b></figref> reveals that the mechanism <b>212</b><i>a </i>can be adjustably moved proximally and distally relative to the mechanism <b>211</b><i>a</i>. The two free ends of the control wire <b>243</b> are releasably attached to the mechanism <b>212</b><i>a</i>. The control wire <b>243</b> is slidable relative to the mechanism <b>211</b><i>a</i>. Therefore, the clinician user can add tension to the control wire <b>243</b> by proximally pulling the mechanism <b>212</b><i>a </i>relative to the mechanism <b>211</b><i>a </i>(e.g., as shown in <figref idref="DRAWINGS">FIG. <b>20</b></figref>). Conversely, the clinician user can relieve tension from the control wire <b>243</b> by distally pushing the mechanism <b>212</b><i>a </i>relative to the mechanism <b>211</b><i>a </i>(e.g., as shown in <figref idref="DRAWINGS">FIG. <b>19</b></figref>).

During the initial stages of the delivery of the prosthetic heart valve <b>100</b>, the three control wire tension adjustment mechanisms of the control handle <b>210</b> will be arranged so as to apply tension to the control wires <b>243</b>, <b>244</b>, and <b>246</b>. That is, the three control wire tension adjustment mechanisms of the control handle <b>210</b> will be oriented as shown in <figref idref="DRAWINGS">FIG. <b>20</b></figref>. Then, in a controlled manner during the delivery/deployment process, the clinician user can individually manipulate the three control wire tension adjustment mechanisms of the control handle <b>210</b> to allow the corresponding portions of the prosthetic heart valve <b>100</b> to expand, and then to be released from the corresponding control wire <b>243</b>, <b>244</b>, or <b>246</b>.

The control handle <b>210</b> also includes a first latch mechanism <b>213</b><i>a</i>, a second latch mechanism <b>213</b><i>b</i>, and a third latch mechanism <b>213</b><i>c</i>. These latch mechanisms <b>213</b><i>a</i>-<i>b </i>are used by the clinician user to releasably detain the mechanisms <b>212</b><i>a</i>-<i>c </i>in the desired proximal/distal position relative to their corresponding mechanism <b>211</b><i>a</i>-<i>c</i>. The latch mechanisms <b>213</b><i>a</i>-<i>b </i>can be deactivated when the clinician user wants to make adjustments to the position of the mechanisms <b>212</b><i>a</i>-<i>c </i>relative to their corresponding mechanism <b>211</b><i>a</i>-<i>c</i>. Then, after making such adjustment(s), the clinician user can reactivate the latch mechanisms <b>213</b><i>a</i>-<i>b </i>to once again detain the mechanisms <b>212</b><i>a</i>-<i>c </i>relative to their corresponding mechanism <b>211</b><i>a</i>-<i>c</i>. In the depicted embodiment, the latch mechanisms <b>213</b><i>a</i>-<i>b </i>are set screws. In some embodiments, the latch mechanisms <b>213</b><i>a</i>-<i>b </i>can comprise various other mechanisms such as, but not limited to, spring-loaded pins, lock collars, collets, and the like.

The control handle <b>210</b> also includes a first control wire fastening mechanism <b>215</b><i>a</i>, a second control wire fastening mechanism <b>215</b><i>b</i>, and a third control wire fastening mechanism <b>215</b><i>c</i>. These control wire fastening mechanisms <b>215</b><i>a</i>-<i>c </i>are used to lock the control wires <b>243</b>, <b>244</b>, and <b>246</b> relative to their corresponding mechanism <b>212</b><i>a</i>-<i>c</i>. When the control wires <b>243</b>, <b>244</b>, and <b>246</b> are locked relative to the mechanisms <b>212</b><i>a</i>-<i>c</i>, the control wires <b>243</b>, <b>244</b>, and <b>246</b> will be tensioned when the mechanisms <b>212</b><i>a</i>-<i>c </i>are pulled proximally relative to their corresponding mechanism <b>211</b><i>a</i>-<i>c</i>. For example (referring to the example depicted by <figref idref="DRAWINGS">FIGS. <b>19</b> and <b>20</b></figref>), when the first control wire fastening mechanism <b>215</b><i>a </i>is activated to lock the first control wire <b>243</b> relative to the mechanism <b>212</b><i>a</i>, moving the mechanism <b>212</b><i>a </i>proximally relative to its corresponding mechanism <b>211</b><i>a </i>will add tension to the first control wire <b>243</b>. Accordingly, the first control wire <b>243</b> will have a higher tension in the arrangement of <figref idref="DRAWINGS">FIG. <b>20</b></figref> as compared to the arrangement of <figref idref="DRAWINGS">FIG. <b>19</b></figref>. In this manner (and referring to <figref idref="DRAWINGS">FIG. <b>15</b></figref>, for example), the clinician user can control the tension of the control wires <b>243</b>, <b>244</b>, and <b>246</b>, which results in controlling the expansion/contraction of the inflow end portion <b>102</b><i>i</i>, the outflow end portion <b>1020</b>, and the posterior flap <b>130</b> respectively.

The control wire fastening mechanisms <b>215</b><i>a</i>-<i>c </i>are also activated by the clinician user when the clinician user wants to fully release the control wires <b>243</b>, <b>244</b>, or <b>246</b> from being engaged with their corresponding portions of the prosthetic heart valve <b>100</b> in order to fully deploy the corresponding portions of the prosthetic heart valve <b>100</b>. For example (and referring to <figref idref="DRAWINGS">FIG. <b>15</b></figref>, for example), when the clinician user wants to fully release the posterior flap <b>130</b> to its fully deployed position, the clinician user can unlock the fourth control wire <b>246</b> from its control wire fastening mechanisms <b>215</b><i>a</i>-<i>c </i>and then proximally pull on one free end of the fourth control wire <b>246</b> until the fourth control wire <b>246</b> becomes fully uncoupled from the posterior flap <b>130</b> as a result of the other free end of the fourth control wire <b>246</b> being pulled through and then away from the posterior flap <b>130</b>. In the depicted embodiment, the control wire fastening mechanisms <b>215</b><i>a</i>-<i>b </i>are set screws. In some embodiments, the control wire fastening mechanisms <b>215</b><i>a</i>-<i>b </i>can comprise various other mechanisms such as, but not limited to, over-center clamps, lock collars, collets, and the like.

The control handle <b>210</b> also includes the first control wire release handle <b>214</b> that is used by the clinician user to pull the third control wire <b>245</b> proximally to release/deploy the one or more anterior flaps <b>120</b><i>a/b </i>of the prosthetic heart valve <b>100</b>. <figref idref="DRAWINGS">FIGS. <b>21</b>-<b>23</b></figref> sequentially illustrate the movements of the distal end portion of the third control wire <b>245</b> as the clinician user proximally pulls the third control wire <b>245</b> using the first control wire release handle <b>214</b>. <figref idref="DRAWINGS">FIG. <b>21</b></figref> shows the distal end portion of the third control wire <b>245</b> in its initial position in which it is fully engaged with the distal tip member <b>241</b>. In this position, the third control wire <b>245</b> holds the one or more anterior flaps <b>120</b><i>a/b </i>adjacent to the inner control catheter <b>240</b> in their low-profile delivery configuration (e.g., as shown in <figref idref="DRAWINGS">FIG. <b>15</b></figref>). <figref idref="DRAWINGS">FIG. <b>22</b></figref> shows the third control wire <b>245</b> in the process of being disengaged from the distal tip member <b>241</b>. <figref idref="DRAWINGS">FIG. <b>23</b></figref> shows the third control wire <b>245</b> fully disengaged from the distal tip member <b>241</b>. In this arrangement, the one or more anterior flaps <b>120</b><i>a/b </i>are released by the third control wire <b>245</b> to expand to their fully deployed configurations.

The control handle <b>210</b> also includes the second control wire release handle <b>218</b> that is used by the clinician user to pull the fifth control wire <b>247</b> proximally to release/deploy the posterior arm <b>150</b> of the prosthetic heart valve <b>100</b>. <figref idref="DRAWINGS">FIGS. <b>24</b>-<b>26</b></figref> sequentially illustrate the movements of the distal end portion of the fifth control wire <b>247</b> as the clinician user proximally pulls the fifth control wire <b>247</b> using the second control wire release handle <b>218</b>. <figref idref="DRAWINGS">FIG. <b>24</b></figref> shows the distal end portion of the fifth control wire <b>247</b> in its initial position in which it is fully engaged with the distal collar <b>231</b>. In this position, the fifth control wire <b>247</b> holds the posterior arm <b>150</b> adjacent to the inner control catheter <b>240</b> in its low-profile delivery configuration (e.g., as shown in <figref idref="DRAWINGS">FIG. <b>15</b></figref>). <figref idref="DRAWINGS">FIG. <b>25</b></figref> shows the fifth control wire <b>247</b> just after being disengaged from the distal collar <b>231</b>.

<figref idref="DRAWINGS">FIG. <b>26</b></figref> shows the fifth control wire <b>247</b> further disengaged from the distal collar <b>231</b>. In this arrangement, the posterior arm <b>150</b> is released by the fifth control wire <b>247</b> to expand to its fully deployed configuration.

<figref idref="DRAWINGS">FIGS. <b>27</b>-<b>36</b></figref> illustrate a series of steps for deploying a prosthetic heart valve (such as the heart valve <b>100</b> described herein in any of its variations) using the heart valve deployment system <b>200</b>. As a non-limiting example, these figures illustrate a transjugular vein approach to the native tricuspid valve <b>10</b> (via the superior vena cava).

<figref idref="DRAWINGS">FIG. <b>27</b></figref> shows a distal end portion of the deployment system <b>200</b> emerging into the right atrium via the superior vena cava. (Note, this depicts a simplified model that shows the annulus <b>12</b> of the native tricuspid valve <b>10</b> and not the entire anatomy of the valve <b>10</b>.) The deployment system <b>200</b> is being advanced over a guidewire that was installed previously. The valve <b>100</b> (not visible) is within the outer sheath catheter <b>220</b> and coupled to the inner control catheter <b>240</b> and the middle deflectable catheter <b>230</b>.

<figref idref="DRAWINGS">FIG. <b>28</b></figref> illustrates the valve <b>100</b> (while the valve <b>100</b> is releasably coupled to the inner control catheter <b>240</b>) after the withdrawal of the outer sheath catheter <b>220</b> and/or the advancement of the inner control catheter <b>240</b> and the middle deflectable catheter <b>230</b>. At this stage, the curved portion <b>242</b> (not visible under the valve <b>100</b>) has become unconstrained and has elastically deflected to its natural curved configuration. The natural curved configuration of the curved portion <b>242</b> facilitates the inner control catheter <b>240</b> to make a relatively tight turn within the right atrium to advance from the vena cava and through the annulus <b>12</b> of the native tricuspid valve <b>10</b> as depicted.

Referring also to <figref idref="DRAWINGS">FIG. <b>37</b></figref> briefly, in some cases an additional curve (or a controllably adjustable curve) of the curved portion <b>242</b> can be needed or desired during the deployment of the valve <b>100</b>. In such a case, some embodiments include a suture (or wire) member <b>255</b> that extends from the retrieval catheter <b>250</b> to the third control wire <b>245</b> that is engaged with the distal tip member <b>241</b>. In that arrangement, a clinician can manipulate the retrieval catheter <b>250</b> (e.g., pull it proximally) to add tension to the suture member <b>255</b> to increase the curvature of the curved portion <b>242</b> of the inner control catheter <b>240</b>. In other words, by manipulating the retrieval catheter <b>250</b> to add tension to the suture member <b>255</b> a clinician can increase the curvature of the inner control catheter <b>240</b> (to be bent beyond the natural curvature of the inner control catheter <b>240</b>). This can be beneficial as the inner control catheter <b>240</b> is manipulated to make the tight turn within the right atrium to advance from the vena cava and through the annulus <b>12</b> of the native tricuspid valve <b>10</b>. After that advancement, and at the appropriate time, the third control wire <b>245</b> can be pulled to disengage the suture member <b>255</b> from the third control wire <b>245</b>.

Further describing the series of steps for deploying the prosthetic heart valve <b>100</b> using the heart valve deployment system <b>200</b>, <figref idref="DRAWINGS">FIGS. <b>29</b> and <b>30</b></figref> illustrate further advancement of the valve <b>100</b> (while the valve <b>100</b> is still releasably coupled to the inner control catheter <b>240</b>). In these images, the middle deflectable catheter <b>230</b> is being deflected (by a first amount in <figref idref="DRAWINGS">FIG. <b>29</b></figref> and a greater amount in <figref idref="DRAWINGS">FIG. <b>30</b></figref>). The deflection of the middle deflectable catheter <b>230</b> adds to the curvature of the inner control catheter <b>240</b> to enable the distal end portion of the inner control catheter <b>240</b> to become directed toward the RVOT after passing through the annulus <b>12</b> (as shown in <figref idref="DRAWINGS">FIG. <b>30</b></figref>).

<figref idref="DRAWINGS">FIGS. <b>31</b> through <b>33</b></figref> illustrate the release process of the portions of the valve <b>100</b> from the inner control catheter <b>240</b> and middle deflectable catheter <b>230</b>. As the portions of the valve <b>100</b> are released, those portions become engaged in the targeted native anatomical locations. In some embodiments, the sequence for releasing/deploying the various portions of the valve <b>100</b> can be: (i) release of the outflow end portion <b>1020</b> of the main body <b>106</b>, (ii) release of the posterior flap <b>130</b>, (iii) release of the inflow end portion <b>102</b><i>i </i>of the main body <b>106</b>, (iv) release of the one or more anterior flaps <b>120</b><i>a</i>-<i>b</i>, and (v) release of the posterior arm <b>150</b>. In some embodiments, other release sequences can be used.

At each step of the release/deployment process, the individual portions of the valve <b>100</b> can be allowed to expand, and prior to full release of the portion, the clinician user can evaluate the positioning and efficacy of the portion. If the clinician user finds the positioning and efficacy of the portion to be satisfactory, then the clinician user can fully release the portion of the valve <b>100</b>. However, if the clinician user is not satisfied, then the clinician user can reapply tension to the corresponding control wire and make positioning adjustments prior to again relieving tension of the corresponding control wire to allow the portion of the valve <b>100</b> to expand once again.

The control wires and/or release pins for the anterior flaps <b>120</b><i>a</i>-<i>b </i>and the posterior flap <b>130</b> are released (as best seen in <figref idref="DRAWINGS">FIG. <b>32</b></figref>, which is a view from the ventricle towards the native tricuspid valve <b>10</b>). In response, the anterior flaps <b>120</b><i>a</i>-<i>b </i>deploy into the RVOT and the posterior flap <b>130</b> deploys to the posterior area of the tricuspid valve <b>10</b> just inferior to the annulus <b>12</b>. In addition, as the posterior flap <b>130</b> deploys, the one or more leaflet engagement members <b>140</b> become coupled with the posterior leaflet <b>11</b><i>p </i>and/or the septal leaflet <b>11</b><i>s </i>to provide migration resistance for the valve <b>100</b>. At this stage, the posterior arm <b>150</b> and/or the anterior arm <b>160</b> (<figref idref="DRAWINGS">FIGS. <b>4</b>-<b>7</b></figref>) can also be deployed if the valve <b>100</b> includes a posterior arm <b>150</b> and/or an anterior arm <b>160</b>. <figref idref="DRAWINGS">FIG. <b>33</b></figref> shows the full release of control wires that are coupled to the main body <b>106</b>. In response, the main body <b>106</b> radially expands into contact and engagement with the annulus <b>12</b>.

<figref idref="DRAWINGS">FIGS. <b>34</b> through <b>36</b></figref> illustrate withdrawal of the deployment system <b>200</b>. When the control wires are disengaged from the valve <b>100</b>, the inner control catheter <b>240</b> and the middle deflectable catheter <b>230</b> can then be withdrawn, leaving the valve <b>100</b> engaged with the anatomy in and around the native tricuspid valve <b>100</b>.

With the deployment system <b>200</b> and guidewire fully withdrawn, the implanted heart valve <b>100</b> is in engagement with the heart <b>1</b> and functioning as a prosthetic tricuspid valve between the RA and the RV. In some embodiments, the heart valve <b>100</b> is positioned such that the main body <b>106</b> is positionally biased toward the anterior portion of the annulus <b>12</b>, which is adjacent the RVOT. Accordingly, the laterally-extending posterior flap <b>130</b> can help to cover and fluidly seal the native tricuspid valve opening within the annulus <b>12</b>, which is not circular in some patients (e.g., with the native valve opening being oblong, oval, or irregularly shaped). In other words, in combination with the main body <b>106</b> of the valve <b>100</b>, the posterior flap <b>130</b> (and, in some cases, the laterally-extending anterior anchoring flaps <b>120</b><i>a</i>-<i>b </i>to a lesser extent) help to cover/occlude and fluidly seal the native tricuspid valve opening which is not circular in some anatomies. In addition, the end portion of the posterior flap <b>130</b> extends into engagement with the posterior shelf <b>11</b> (<figref idref="DRAWINGS">FIG. <b>5</b></figref>) and/or with the wall of the RV just inferior to the annulus <b>12</b> to provide anchoring and migration resistance. Accordingly, the posterior flap <b>130</b> can perform both sealing and anchorage.

<figref idref="DRAWINGS">FIGS. <b>37</b>-<b>44</b></figref> sequentially illustrate a process of retrieving the prosthetic heart valve <b>100</b>. This retrieval process can take place after the expression of the valve <b>100</b> from the outer sheath catheter <b>220</b>, but prior to the release of the valve <b>100</b> from the control wires. Such a retrieval process may be beneficial, for example, if the clinician user has relaxed one or more of the looped control wires <b>243</b>, <b>244</b>, and <b>246</b> (<figref idref="DRAWINGS">FIG. <b>9</b></figref>) and then finds that the valve <b>100</b> would not be suitable for full deployment, for whatever reason. In such a case, the clinician user can reapply the tension to the control wires <b>243</b>, <b>244</b>, and <b>246</b>, and then proceed with the illustrated retrieval process.

As shown in <figref idref="DRAWINGS">FIG. <b>37</b></figref>, in some embodiments the deployment system <b>200</b> can include a retrieval catheter <b>250</b>. That is, the deployment system <b>200</b> can include the retrieval catheter <b>250</b> in addition to the control handle <b>210</b> (not shown), the outer sheath catheter <b>220</b>, the middle deflectable catheter <b>230</b>, the inner control catheter <b>240</b>, and the control wires <b>243</b>, <b>244</b>, <b>245</b>, <b>246</b>, and <b>247</b>.

In the depicted embodiment, the retrieval catheter <b>250</b> includes a catheter shaft <b>252</b>, a funnel-shaped member <b>254</b>, two snare arms <b>256</b><i>a</i>-<i>b</i>, and a snare wire <b>258</b>. The funnel-shaped member <b>254</b> is attached at a distal end portion of the catheter shaft <b>252</b>. The snare arms <b>256</b><i>a</i>-<i>b </i>and the snare wire <b>258</b> are positioned within, and distally extend from, the funnel-shaped member <b>254</b>.

The catheter shaft <b>252</b> of the retrieval catheter <b>250</b> defines a lumen. The middle deflectable catheter <b>230</b> extends within the lumen of the catheter shaft <b>252</b>, and extends within the funnel-shaped member <b>254</b>. The inner control catheter <b>240</b> extends within the lumen of the middle deflectable catheter <b>230</b>. The retrieval catheter <b>250</b> extends within the lumen of the outer sheath catheter <b>220</b>.

In some embodiments, the retrieval catheter <b>250</b> is only expressed from the outer sheath catheter <b>220</b> if/when the clinician user desires to initiate the valve retrieval process. Otherwise, the clinician user can keep the outer sheath catheter <b>220</b> remaining over the funnel-shaped member <b>254</b>.

In some embodiments, the funnel-shaped member <b>254</b> is self-expandable. That is, when the funnel-shaped member <b>254</b> is expressed from the confines of the outer sheath catheter <b>220</b>, the funnel-shaped member <b>254</b> will self-expand from its low-profile delivery configuration to its expanded conical shape as shown. In some embodiments, the funnel-shaped member <b>254</b> is constructed of a wire framework. For example, in some embodiments the funnel-shaped member <b>254</b> has a stent-like construction. In some such embodiments, the funnel-shaped member <b>254</b> can be constructed of a metal tube (e.g., Nitinol, stainless steel, alloy steel, titanium, etc.) that is laser cut and shape set into the conical shape as shown.

In some embodiments, the two snare arms <b>256</b><i>a</i>-<i>b </i>are arranged on opposite sides of the deflectable catheter <b>230</b> (e.g., at approximately 180° opposite of each other). The snare wire <b>258</b> extends between the distal ends of the snare arms <b>256</b><i>a</i>-<i>b </i>to form a loop, and also extends proximally to the control handle <b>210</b> (not shown). Accordingly, the clinician user can proximally pull on the snare wire <b>258</b> to cinch the looped snare wire <b>258</b> between the snare arms <b>256</b><i>a</i>-<i>b </i>to a smaller diameter.

<figref idref="DRAWINGS">FIG. <b>38</b></figref> shows the snare wire <b>258</b> being positioned around the main body <b>106</b> of the prosthetic heart valve <b>100</b>. To achieve this arrangement, the valve <b>100</b> is pulled proximally to position it within the looped snare wire <b>258</b>.

<figref idref="DRAWINGS">FIG. <b>39</b></figref> shows the snare wire <b>258</b> being cinched (tightened) around the main body <b>106</b> of the prosthetic heart valve <b>100</b>. The cinching reduces the outer diameter of the valve <b>100</b> so that the valve <b>100</b> can be pulled within the interior of the expanded funnel-shaped member <b>254</b>.

<figref idref="DRAWINGS">FIG. <b>41</b></figref> shows the prosthetic heart valve <b>100</b>, while cinched to a reduced outer diameter, being pulled into the funnel-shaped member <b>254</b>.

<figref idref="DRAWINGS">FIGS. <b>41</b>-<b>44</b></figref> progressively show the final steps of the retrieval process as the funnel-shaped member <b>254</b> and the prosthetic heart valve <b>100</b> are being pulled into the outer sheath catheter <b>220</b>. This can be performed by the clinician user pulling the inner catheter <b>240</b>, the middle deflectable catheter <b>230</b>, and the retrieval catheter <b>250</b> proximally in relation to the outer sheath catheter <b>220</b>.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment in part or in whole. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and/or initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Although a number of implementations have been described in detail above, other modifications are possible. For example, the steps depicted in the figures do not require the particular order shown, or sequential order, to achieve desirable results. In addition, other steps may be provided, or steps may be eliminated, from the described flows, and other components may be added to, or removed from, the described systems. Accordingly, other implementations are within the scope of the following claims.